Identity
- Trade Name
- Isodry FDA UDI
- Generic Name
- Dental suction system FDA UDI
- Device Name
- Lever Set, Isovac EUDAMEDFDA UDI
- Model / Reference
- PIV0102 EUDAMEDFDA UDI
- Description
- Lever Set, Isovac FDA UDI
Identifiers
- Catalog Number
- PIV0102 FDA UDI
- Primary DI / UDI-DI
- 00810032661069 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810032661069 EUDAMED
- FDA Product Code
- EBR FDA UDI
- EMDN Code
- Q019001 SALIVA ASPIRATORS AND SALIVA ABSORBENTS EUDAMED
- GMDN Term
- Dental suction system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.6640 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Lever Set, Isovac by Zyris, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00810032661069 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Zyris, Inc.
- EUDAMED SRN
- US-MF-000034843
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 65c82905-10f6-43fc-ab2c-d299c23ae6c8 61 fields · synced Jul 18, 2026
- FDA UDI 9d94a11b-b643-4c48-be91-2d2a4f8e572c 35 fields · synced May 30, 2026